Lupus & antiphospholipid syndrome
Efficacy and safety of upadacitinib as monotherapy or combined with elsubrutinib for the treatment of systemic lupus erythematosus: results through 104 weeks in a long-term extension study
Authors' conclusion
In this LTE study, upadacitinib monotherapy and upadacitinib/elsubrutinib combined were well tolerated and continued to demonstrate beneficial effects on SLE disease activity, glucocorticoid dose and flares through 104 weeks.
Study context
- Population
- Adults with moderately to severely active systemic lupus erythematosus (SLE) who completed the 48-week phase 2 SLEek study
- Participants
- 127 adults
- Comparison
- Upadacitinib 30 mg QD vs upadacitinib 30 mg/elsubrutinib 60 mg QD vs placebo switched to upadacitinib/elsubrutinib
Methodological details1-year long-term extension
- 1-year long-term extension
Primary result
As reported in the abstract
Efficacy responses (SRI-4, BICLA, Lupus Low Disease Activity State (LLDAS)) · week 104
- Efficacy responses maintained or increased from weeks 48 to 104 in all groups
Further findings
SRI-4 response · week 104
BICLA response · week 104
LLDAS · week 104
GC dose and flares · weeks 48 through 104
- Mean daily GC dose reduced and flare incidence maintained or further reduced in all treatment groups
Original publication
Efficacy and safety of upadacitinib as monotherapy or combined with elsubrutinib for the treatment of systemic lupus erythematosus: results through 104 weeks in a long-term extension study. RMD Open. Published 18 August 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →